NCT01731366

Brief Summary

Objective: To identify how specific changes of the whole grain content in the diet affect the host-gut microbiome interactions with implications for metabolic health . Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60 participants will be included. Intervention: low vs. high whole grain intake.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

1.5 years

First QC Date

November 15, 2012

Last Update Submit

September 1, 2014

Conditions

Metabolic DiseaseInjury of Gastrointestinal Tract

Outcome Measures

Primary Outcomes (2)

  • HOMA-IR

    Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)

    At the end of the intervention periods

  • Metagenomic profile

    Altered quantitative metagenomics at bacterial gene- and species levels, which is a non-specific outcome, but included as the main hypothesis of the project is to test if HOMA-IR is affected via changes in the gut microbiome.

    At the end of the intervention periods

Secondary Outcomes (18)

  • Mean intestinal transit time

    At the end of the intervention periods

  • Gastrointestinal permeability, Lactulose/ mannitol ratio

    At the end of the intervention periods

  • Colonic fermentation

    At the end of the intervention periods

  • Saliva microbial flora

    At the end of the intervention periods

  • Blood pressure

    At the end of the intervention periods

  • +13 more secondary outcomes

Other Outcomes (3)

  • 4-days precoded food diary

    December 2014

  • n-3 fatty acid status

    At the end of the intervention periods

  • Alkyresorcinol

    At the end of the intervention periods

Study Arms (2)

Refined grain

PLACEBO COMPARATOR

Refined grain diet: Participants consume less than 10 g of whole grain per day (corresponds to the whole grain intake below the 10th percentile of the population)

Other: Refined grain

Whole grain

ACTIVE COMPARATOR

Whole grain diet: Participants consume more than 75g of whole grain per day (corresponds to the whole grain intake of the 90th percentile of the population)

Other: Whole grain

Interventions

Whole grainOTHER

Whole grain diet: Participants consume more than 75g of whole grain per day (corresponds to the whole grain intake of the 90th percentile of the population)

Whole grain
Refined grainOTHER

Refined grain diet: Participants consume less than 10 g of whole grain per day (corresponds to the whole grain intake below the 10th percentile of the population)

Refined grain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI): 25 - 35 kg/m2
  • No medical prescribed diet
  • Weight stable
  • No blood donation during the study
  • Intense sporting activities less than 10h/ week
  • Alcohol consumption less than 14 units/ week (female) and 21 units/ week (male)
  • Signed written consent

You may not qualify if:

  • Pharmacological treatment; hypertension, diabetes and blood lipid regulation
  • Lactating (or lactating, 6 weeks ago), pregnant (or pregnant, 3 months ago) or wish to become pregnant during the study
  • Participation in another biomedical trial 1 month prior to study start
  • Diagnosed with any form of diabetes, celiac disease or chronic pancreatitis
  • Reported chronic gastrointestinal disorders
  • Antibiotic treatment for 3 month prior to study start
  • Intake of vitamin, mineral, or pre- or probiotic supplements for 1 month prior to study start
  • Blood hemoglobin \< 7.0 mmol/l
  • Blood donation within 1 month prior to study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, University of Copenhagen

Fredriksberg, 1958, Denmark

Location

Related Publications (3)

  • Lind MV, Lauritzen L, Vestergaard H, Hansen T, Pedersen O, Kristensen M, Ross AB. One-carbon metabolism markers are associated with cardiometabolic risk factors. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):402-410. doi: 10.1016/j.numecd.2018.01.005. Epub 2018 Jan 31.

    PMID: 29499850DERIVED

  • Roager HM, Vogt JK, Kristensen M, Hansen LBS, Ibrugger S, Maerkedahl RB, Bahl MI, Lind MV, Nielsen RL, Frokiaer H, Gobel RJ, Landberg R, Ross AB, Brix S, Holck J, Meyer AS, Sparholt MH, Christensen AF, Carvalho V, Hartmann B, Holst JJ, Rumessen JJ, Linneberg A, Sicheritz-Ponten T, Dalgaard MD, Blennow A, Frandsen HL, Villas-Boas S, Kristiansen K, Vestergaard H, Hansen T, Ekstrom CT, Ritz C, Nielsen HB, Pedersen OB, Gupta R, Lauritzen L, Licht TR. Whole grain-rich diet reduces body weight and systemic low-grade inflammation without inducing major changes of the gut microbiome: a randomised cross-over trial. Gut. 2019 Jan;68(1):83-93. doi: 10.1136/gutjnl-2017-314786. Epub 2017 Nov 1.

    PMID: 29097438DERIVED

  • Lind MV, Madsen ML, Rumessen JJ, Vestergaard H, Gobel RJ, Hansen T, Lauritzen L, Pedersen OB, Kristensen M, Ross AB. Plasma Alkylresorcinols Reflect Gluten Intake and Distinguish between Gluten-Rich and Gluten-Poor Diets in a Population at Risk of Metabolic Syndrome. J Nutr. 2016 Oct;146(10):1991-1998. doi: 10.3945/jn.116.236398. Epub 2016 Sep 14.

    PMID: 27629576DERIVED

Related Links

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Whole Grains

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Edible GrainCrops, AgriculturalFoodDiet, Food, and NutritionPhysiological PhenomenaSeedsFood and Beverages

Study Officials

  • Lotte Lauritzen, Associate professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

August 1, 2012

Primary Completion

February 1, 2014

Study Completion

December 1, 2015

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations

DK(1)